Amarin Corp Plc (AMRN)

[Williams4076]

When HHS OIG is threatening Physicians with Medicaid and Medicare fraud, it's hard to grow scripts.

When this is done using Government means on false pretense this is a crime.

CMS was used to destroy DNDN.

To whom it may concern,


Your June 2015 Data brief makes a GRAVE error comparing the drug Vascepa to "Over-the-counter supplements of omega-3”. OTC Fish Oil supplements are NOT drugs regulated by the FDA or substitutable by any means. Such a practice would put "substituted patients" at imminent harm of a cardio vascular event or DEATH, violate the right of Physicians to practice medicine, and could be considered a substitution of a counterfeit drug! Under Federal Regulation:

SEC. 201. [21 U.S.C.321] CHAPTER II—DEFINITIONS (g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

Vascepa is recognized in the official United States Pharmacopoeia to treat very High Triglycerides, and by the NIH “Other uses for this medicine”. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a613024.html#other-uses Under US law it is not lawful to compare an OTC supplement to an FDA regulated drug. OTC “Fish Oils” do NOT undergo the same rigorous manufacturing checks and balances a fully regulated FDA product must endure. While it is well known throughout the scientific community “fish oils” have been linked to decreased cardiovascular events, even supported by a Supreme Court ruling, the FDA does not regulate the specific contents of “fish oil”. These studies without question used “Fish Oils” not a harmful trans-fat alternative or other unknown fatty oil.

The timing of HHS OIG Data Brief June 2015 OEI-02-15-00190 mentioning Amarin’s drug Vascepa appears to be in retaliation for Amarin filing a First Amendment lawsuit (SDNY 1:15-cv-03588-PAE Amarin Pharma, Inc. et al v. United States Food & Drug Administration et al) against FDA. This HHS OIG report can be found at this link: http://oig.hhs.gov/oei/reports/oei-02-15-00190.pdf The report implies physician should recommend ---out of pocket--- OTC “fish oils” be substituted for Vascepa. This report is in violation of Federal Law for the above reasons.

I will file an immediate complaint with both House Appropriations Committee and Senate HELP committee if your agency’s doesn’t print an immediate retraction and press announcement.

Please communicate with Virginia Behr, CDER Ombuds to get full background details. My complaint will be filled by Monday June 30th.

You are welcome to contact me if you have scientific or REAL AMERICAN regulatory questions.





Thanks You for your Compliance with US Law,